(31 days)
No
The device is a dip-and-read test strip with visual comparison to a color chart, explicitly stating no additional laboratory equipment is needed and no mention of AI/ML is found.
No.
This device is an in vitro diagnostic (IVD) device used to test patient urine levels of various substances, which helps healthcare professionals with diagnosis, not treatment.
Yes
The device is a diagnostic device because its "Intended Use / Indications for Use" states that it is "a dip-and-read test strip for semi-quantitative urinalysis" to "test semi-quantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen." This information is used to aid in the diagnosis of various health conditions.
No
The device is a physical reagent strip for urinalysis that is read visually. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "semi-quantitative urinalysis" to test for various substances in patient urine. This is a diagnostic purpose performed in vitro (outside the body).
- Device Description: The description details a "dip-and-read test strip" with "reagent test areas" that react with urine. This is a classic description of an in vitro diagnostic device.
- Performance Studies: The document describes clinical evaluations where the device is used to test urine samples and the results are compared to a predicate device. This is consistent with the testing and validation required for IVDs.
- Predicate Devices: The listing of predicate devices, which are also urinalysis reagent strips, further confirms that this device falls within the category of IVDs.
The device performs tests on biological samples (urine) outside of the body to provide information about a patient's health status, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semi-quantitative urinalysis. DIASCREEN® Reagent Strips have been developed to allow health care professionals to test semi-quantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart.
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip and is intended for use as an in vitro diagnostic aid using urine specimens. The strip contains solid phase reagent areas affixed to a plastic strip and is provided in a dry reagent format.
The strip provides qualitative and semi-quantitative tests for specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart for each concentration range. No additional reagents and laboratory equipment are required. The reagent strips are packaged in a plastic vial containing a desiccant. The test strips must be kept tightly capped in the vial to assure reagent reactivity. The directions must be followed exactly and it is necessary to use fresh, well-mixed, uncentrifuged urine for optimal results.
Product codes
LJX
Device Description
DIASCREEN® Reagent Strips are plastic strips to which are affixed reagent test areas. Several product configurations are included with this submission, but all configurations are limited to one, some or all of the following tests: specific gravity, ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen.
The reagent test areas on the DIASCREEN® Reagent Strips are ready to use upon removal from the bottle and the entire reagent strip is disposable after use. The strips are to be read visually, requiring no additional laboratory equipment for testing.
The directions must be followed exactly. Accurate timing is essential to provide optimal results. The reagent strips must be kept in the original bottle containing the desiccant with the cap tightly closed to maintain reagent activity. To obtain optimal results it is necessary to use fresh, well-mixed, uncentrifuged urine.
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip intended for use as an in-vitro diagnostic aid using urine specimens. DIASCREEN® Reagent Strips have been developed to allow health care professionals to semi-quantitatively determine levels of specific gravity, leukocyte, ketone, glucose, protein, blood, nitrite, pH, bilirubin, and urobilinogen in patient urine by visual comparison with a color chart of each concentration range. No additional reagents or laboratory equipment are required. These reagent strips are packaged in a plastic vial containing a desiccant. The test strips must be maintained tightly capped in the plastic vial to assure reagent activity. The directions-for-use must be followed exactly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two independent laboratory evaluations of the DIASCREEN® Urine Leukocyte Test were conducted. The purpose of the laboratory evaluations was to establish the performance of the leukocyte test when compared to a "510(k) approved" marketed urinalysis strip system.
Clinical Evaluation One was under the direction of James Jackson, MT(ASCP) CLS, Ph.D. at Wichita State University Department of Medical Technology (Site 1). The study consisted of comparing the performance of two (2) manufactured lots of DIASCREEN® Leukocyte Reagent Strips with the marketed product (Baver Multistix 10 SG).
Fresh urine samples were obtained at the medical facility. The comparison strips, Bayer Multistix 10 SG Reagent Strips, were furnished by Dia-Screen.
Fresh, well-mixed, and uncentrifuged urine from a mixed patient population was reacted with the DIASCREEN® Reagent Strips and the results were read by visual comparison with the DIASCREEN® color chart. Results of these readings were compared to results measured by Multistix 10 SG Reagent Strips.
Clinical Evaluation Two was conducted under the direction of Mvron Rapkin. Technovations Inc. at two clinical sites. Reagent strips and urine samples were handled as described above.
A summary of the data obtained from the two clinical evaluations follows. Table I presents the percentage of responses of the DIASCREEN® Strips that are within the same color block and that are within plus or minus one color block of Baver Leukocyte results. Table II presents a similar analysis for two lots of the DIASCREEN® Reagent Strips tested during Clinical Evaluation One. The data used to compile these tables is presented for each evaluation in charts where the shaded region represents the within plus or minus one color block range.
DIASCREEN® Lot 1 versus Bayer Multistix Table I.
Evaluation One-Lot 1: Same Color Block - 35/39 (90%), Within 1 Color Block - 39/39 (100%)
Evaluation One-Lot 2: Same Color Block - 35/39 (90%), Within 1 Color Block - 39/39 (100%)
Evaluation Two: Same Color Block - 237/279 (85%), Within 1 Color Block - 268/279 (96%)
DIASCREEN® Lot 1 versus DIASCREEN® Lot 2 Table II.
Evaluation One: Same Color Block - 35/39 (97%), Within 1 Color Block - 39/39 (100%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7675 Leukocyte peroxidase test.
(a)
Identification. A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.(b)
Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
Ka81555J
Summary of Safety and Effectiveness
April 22, 1998
The following information is provided as a summary of safety and effectiveness information for the DIASCREEN® Reagent Strip System. The reagent strips which are the subject of this pre-market notification contain one new reagent area for leukocytes in urine. The other nine reagent areas have been previously reviewed.
-
Common Name: Visual Reagent Test Strip for Urinalysis (al
Trade/Proprietary Name: DIASCREEN® Reagent Strips, in many different configurations with as many different product codes. DIASCREEN® the registered trademark of Dia-Screen is Corporation. -
[b] Establishment Registration Number: 2183670
Chronimed Inc. Bury Drive Eden Prairie, MN 55346 -
Contact Person: lcl
Vicki Frawley 5182 West 76th Street Minneapolis. MN 55439 Phone: (612) 835-3446 ext. 17 Fax: (612) 835-9406 -
[d] Intended Use
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semi-quantitative urinalysis. DIASCREEN® Reagent Strips have been developed to allow health care professionals to test semi-quantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart.
1
Product Description lel
DIASCREEN® Reagent Strips are plastic strips to which are affixed reagent test areas. Several product configurations are included with this submission, but all configurations are limited to one, some or all of the following tests: specific gravity, ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen.
The reagent test areas on the DIASCREEN® Reagent Strips are ready to use upon removal from the bottle and the entire reagent strip is disposable after use. The strips are to be read visually, requiring no additional laboratory equipment for testing.
The directions must be followed exactly. Accurate timing is essential to provide optimal results. The reagent strips must be kept in the original bottle containing the desiccant with the cap tightly closed to maintain reagent activity. To obtain optimal results it is necessary to use fresh, well-mixed, uncentrifuged urine.
Corporation has previously received Dia-Screen determination of substantial equivalence for complete lines of reagent strips for urinalysis which have been marketed under the Bioscan label (K940043) and the DIASCREEN® label (K952971. K961375). The intended use of the strips that are the subject of this new premarket notification is exactly the same as the Bioscan (K940043) and DIASCREEN® (K952971, K961375) strips which were reviewed previously.
Chronimed Inc. purchased Dia-Screen Corporation on March The DIASCREEN® Reagent Strips will 16. 1998. be manufactured by Chronimed Inc. for distribution by Chronimed Inc.
[f] Substantial Equivalence
The intended use of the strips which are the subject of this new pre-market notification is exactly the same as the strips which were reviewed previously (K940043, K943008, K952971, K961375. K971976).
2
The design and function of the new DIASCREEN® Reagent Strips are the same as the design and function of both the Bioscan and DIASCREEN® Reagent Strips which have been previously reviewed under pre-market notifications K940043, K943008, K952971, K961375, and K971976.
Ship ... ..
The DIASCREEN® Reagent Strips for Urinalysis are substantially equivalent to the previous line of DIASCREEN® Reagent Strips (K943008, K961375) and the Bayer Multistix 10 SG Reagent Strips for Urinalysis. The new reagent area for leukocytes in urine on the DIASCREEN® Reagent Strips is substantially equivalent to the reagent area for leukocytes in urine on the Bayer Multistix 10 SG reagent strips.
Characteristics of the Bayer Multistix 10 SG system and the previous DIASCREEN® system are compared with the subject DIASCREEN® system in the following table.
3
| Strip Name
Distributor | This 510 (k)
DIASCREEN®
Dia-Screen | Prevoius 510 (k)
DIASCREEN®
Dia-Screen | Bayer Multistix 10 SG
Bayer |
|---------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Reagents for: | | | |
| Leukocyte | 2-(3-Methoxyphenyl)-4-
thiazol
Diazonium salt | Not offered | Derivatized pyrrole amino
acid ester
Diazonium salt
Buffer |
| Specific
Gravity | Bromothymol blue
Methyl red
Polyvinyl phosphate | Bromthymol blue
Detergent | Bromthymol blue
Poly (methyl vinyl-ether
maleic anhydride) |
| Ketones | Sodium nitroprusside | Sodium nitroprusside | Sodium nitroprusside
Buffer |
| Glucose | Glucose oxidase
Peroxidase
Potassium iodide | Glucose oxidase
Peroxidase
Potassium iodide | Glucose oxidase
Peroxidase
Potassium iodide
Buffer |
| Protein | Tetrabromphenol blue
Citric acid
Trisodium citrate | Tetrabromphenol blue
Citric acid
Trisodium citrate | Tetrabromphenol blue
Buffer |
| Blood | 2,5 Dimethylhexane-
2,5-dihydroperoxide
3,3',5,5'-
Tetramethylbenzidine | 2,5 Dimethylhexane-
2,5-dihydroperoxide
3,3',5,5'-
Tetramethylbenzidine | Diisopropylbenzene-
dihydroperoxide
3,3',5,5'-
Tetramethylbenzidine |
.
대부 이 대
4
| This 510 (k) | Prevoius 510 (k) | ||
|---|---|---|---|
| Strip Name | DIASCREEN® | DIASCREEN® | Bayer Multistix 10 SG |
| Distributor | Dia-Screen | Dia-Screen | Bayer |
| Reagents for: | |||
| Nitrite | p-Arsanilic acid | ||
| Hydroxy(3)-1,2,3- | |||
| tetrahydrobenzo(h)quinoline | p-Arsanilic acid | ||
| Hydroxy(3)-1,2,3- | |||
| tetrahydrobenzo(h)quinoline | p-Arsanilic acid | ||
| 1,2,3,4-Tetrahydro- | |||
| benzo(h)quinoline-3-ol | |||
| Buffer | |||
| pH | Bromthymol blue | ||
| Methyl red | Bromthymol blue | ||
| Methyl red | Bromthymol blue | ||
| Methyl red | |||
| Bilirubin | 2,4 Dichlorobenzene- | ||
| diazonium salt | |||
| Sulfasalicylic acid | 2,4 Dichlorobenzene- | ||
| diazonium salt | 2,4-Dichloroaniline- | ||
| diazonium salt | |||
| Buffer | |||
| Urobilinogen | 4-methoxybenzene- | ||
| diazonium salt | |||
| Metaphosphoric acid | Dimethylaminobenzaldede | Diethylaminobenzaldede |
5
| Strip Name
Distributor | This 510 (k)
DIA SCREEN®
Dia-Screen | Previous 510 (k)
DIA SCREEN®
Dia-Screen | Multistix 10 SG
Bayer |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Packaged with
Desiccant | Yes | Yes | Yes |
| Control Available | Yes | Yes | Yes |
| Time required to
read strips | 30 to 120 seconds | 30-60 seconds | 30 to 120 seconds |
| Storage | Between 15 - 30 °C (59°-
86° F). Do Not Store in
refrigerator or freezer. Do
not expose to moisture,
heat or light. | Between 15 - 30 °C (59°-
86° F). Do Not Store in
refrigerator or freezer. Do
not expose to moisture,
heat or light | Between 15°-30° C (59°-
86° F) Do Not Store in
Direct Sunlight |
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1
SS and E Page 6
:
6
| Strip Name
Distributor | This 510 (k)
DIA SCREEN®
Dia-Screen | Previous 510 (k)
DIA SCREEN®
Dia-Screen | Multistix 10 SG
Bayer |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Expected Values: | | | |
| Leukocyte | Normally no leukocytes
are detected in urine.
Individually observed
trace results may be of
questionable clinical
significance. Positive
results found in random
specimens from females
may be due to vaginal
contamination. | Not applicable. | Normal urine specimens
generally yield negative
results. Positive results
(small or greater) are
clinically significant.
However, trace results
observed repeatedly may
be clinically significant/
Positive and repeated
trace results indicate the
need for testing of the
patient and/or urine
specimen according to
medically accepted
procedures for pyuria.
Positive results may be
found with random
specimens from females
due to contamination by
vaginal discharge |
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| Strip Name | This 510 (k)
DIA SCREEN® | Previous 510 (k)
DIA SCREEN® | Multistix 10 SG
Bayer |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Distributor
Expected Values: | Dia-Screen | Dia-Screen | Bayer |
| Leukocyte | Normally no leukocytes
are detected in urine.
Individually observed
trace results may be of
questionable clinical
significance. Positive
results found in random
specimens from females
may be due to vaginal
contamination. | Not applicable. | Normal urine specimens
generally yield negative
results. Positive results
(small or greater) are
clinically significant.
However, trace results
observed repeatedly may
be clinically significant/
Positive and repeated
trace results indicate the
need for testing of the
patient and/or urine
specimen according to
medically accepted
procedures for pyuria.
Positive results may be
found with random
specimens from females
due to contamination by
vaginal discharge. |
- Art of Schristop,
. . . .
SS and E Page 8
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Strip Name
Distributor
Expected Values: | This 510 (k)
DIA SCREEN®
Dia-Screen | Previous 510 (k)
DIA SCREEN®
Dia-Screen | Multistix 10 SG
Bayer |
|-----------------------------------------------|-------------------------------------------|-----------------------------------------------|-----------------------------|
| Specific Gravity | Random urines vary from | Random urines vary from | Random urines vary from |
| | 1.001-1.035. Twenty-four | 1.001-1.035. Twenty-four | 1.001-1.035. Twenty-four |
| | hour urines from normal | hour urines from normal | hour urines from normal |
| | adults with normal diets | adults with normal diets | adults with normal diets |
| | and fluid intake will have | and fluid intake will have | and fluid intake will have |
| | a specific gravity of | a specific gravity of | a specific gravity of |
| | 1.016-1.022 | 1.016-1.022 | 1.016-1.022 |
| Ketones | Should not be detected in | Should not be detected in | Normal specimens yield |
| | normal urine. | normal urine. | negative results. |
| Glucose | None found in normal | None found in normal | None found in normal |
| | urine. Concentrations of | urine. Concentrations of | urine. Concentration of |
| | 100 mg/dL may be | 100 mg/dL may be | 100 mg/dL may be |
| | considered abnormal. | considered abnormal. | considered abnormal. |
| Protein | Normal specimens | Normal specimens | Normal specimens |
| | ordinarily contain some | ordinarily contain some | ordinarily contain some |
| | protein (0-4 mg/dL). | protein (0-4 mg/dL). | protein (0-4 mg/dL). A |
| | Persistent results of trace | Persistent results of trace | color matching any "+" |
| | or higher indicate | or higher indicate | block indicates significant |
| | significant proteinuria. | significant proteinuria. | proteinuria |
ここにつきていたのはなくなると、ここで
:
9
Clinical Laboratory Evaluation of DIASCREEN® Strips
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip intended for use as an in-vitro diagnostic aid using urine specimens. DIASCREEN® Reagent Strips have been developed to allow health care professionals to semi-quantitatively determine levels of specific gravity, leukocyte, ketone, glucose, protein, blood, nitrite, pH, bilirubin, and urobilinogen in patient urine by visual comparison with a color chart of each concentration range. No additional reagents or laboratory equipment are required. These reagent strips are packaged in a plastic vial containing a desiccant. The test strips must be maintained tightly capped in the plastic vial to assure reagent activity. The directions-for-use must be followed exactly.
Two independent laboratory evaluations of the DIASCREEN® Urine Leukocyte Test were conducted. The purpose of the laboratory evaluations was to establish the performance of the leukocyte test when compared to a "510(k) approved" marketed urinalysis strip system.
Clinical Evaluation One was under the direction of James Jackson, MT(ASCP) CLS, Ph.D. at Wichita State University Department of Medical Technology (Site 1). The study consisted of comparing the performance of two (2) manufactured lots of DIASCREEN® Leukocyte Reagent Strips with the marketed product (Baver Multistix 10 SG).
Fresh urine samples were obtained at the medical facility. The comparison strips, Bayer Multistix 10 SG Reagent Strips, were furnished by Dia-Screen.
Fresh, well-mixed, and uncentrifuged urine from a mixed patient population was reacted with the DIASCREEN® Reagent Strips and the results were read by visual comparison with the DIASCREEN® color chart. Results of these readings were compared to results measured by Multistix 10 SG Reagent Strips.
Clinical Evaluation Two was conducted under the direction of Mvron Rapkin. Technovations Inc. at two clinical sites. Reagent strips and urine samples were handled as described above.
A summary of the data obtained from the two clinical evaluations follows. Table I presents the percentage of responses of the DIASCREEN® Strips that are within the same color block and that are within plus or minus one color block of Baver Leukocyte results. Table II presents a similar analysis for two lots of the DIASCREEN® Reagent Strips tested during Clinical Evaluation One. The data used to compile these tables is presented for each evaluation in charts where the shaded region represents the within plus or minus one color block range.
10
DIASCREEN® versus Bayer Clinical Correlation
was and the country of
DIASCREEN® Lot 1 versus Bayer Multistix Table I.
| Same Color Block | Within 1 Color Block | |||
|---|---|---|---|---|
| Evaluation One-Lot 1 | 35/39 | 90% | 39/39 | 100% |
| Evaluation One-Lot 2 | 35/39 | 90% | 39/39 | 100% |
| Evaluation Two | 237/279 | 85% | 268/279 | 96% |
DIASCREEN® Lot 1 versus DIASCREEN® Lot 2 Table II.
| ----------
Evaluation One- | Same Color Block | | Within 1
Color Block | |
|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------|---------------------------------------------------------------------------|
| of
LOT /
check of the consistence and a commended in the consistent of the comments of the comments of | 35/39
of Acres of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children | 97%
of the property of the produced the program and the county of | 39/39 | 100%
Company of Canadian Call Property of Children Company of Children |
11
Page_1 of 1
510(k) Number (if known); $69 x 155
Device Name: DIASCREEN Reagent Strips
Indications For Use:
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip and is intended for use as an in vitro diagnostic aid using urine specimens. The strip contains solid phase reagent areas affixed to a plastic strip and is provided in a dry reagent format.
The strip provides qualitative and semi-quantitative tests for specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart for each concentration range. No additional reagents and laboratory equipment are required. The reagent strips are packaged in a plastic vial containing a desiccant. The
test strips must be kept tightly capped in the vial to assure reagent reactivity. The directions must be followed exactly and it is necessary to use fresh, well-mixed, uncentrifuged urine for optimal results.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use______ |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K981555 |
|---|---|
| --------------- | --------- |
12
NT OF HEALT
Image /page/12/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
JUN 11 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Vicki Frawley . Chronimed Inc. 5182 West 76th Street Minneapolis, Minnesota ਦੇ ਦੇ ਤੇ ਰ
Re: K981555 DIASCREEN® Leukocyte Reagent Strip for Urinalysis Requlatory Class: II Product Code: LJX Dated: April 22, 1998 Received: May 1, 1998
Dear Ms. Frawley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
13
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
14
Page == 1 = of i
510(k) Number (if known); 40 9 3 15 55
Device Name: DIASCREEN Reagent Strips
Indications For Use:
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip and is intended for use as an in vitro diagnostic aid using urine specimens. The strip contains solid phase reagent areas affixed to a plastic strip and is provided in a dry reagent format.
The strip provides qualitative and semi-quantitative tests for specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart for each concentration range. No additional reagents and laboratory equipment are required. The reagent strips are packaged in a plastic vial containing a desiccant. The
test strips must be kept tightly capped in the vial to assure reagent reactivity. The directions must be followed exactly and it is necessary to use fresh, well-mixed, uncentrifuged urine for optimal results.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | ✓ |
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use ______ | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K981555 |
|---|---|
| --------------- | --------- |